ANRS CO24 OncoVIHAC (Onco VIH Anti Checkpoint)
- Conditions
- HIV Infected Patients With Cancer Treated by ICPi
- Registration Number
- NCT03354936
- Lead Sponsor
- ANRS, Emerging Infectious Diseases
- Brief Summary
A Multicenter, Observational, National Cohort for HIV Infected Patients with a Cancer treated by Immune-Checkpoint Inhibitors (ICPi) for less than one month or to be treated with an ICPi such as anti-PD-1 or anti-PDL-1 or anti-CTLA4, monitored in some French hospitals .
The objective of the study is to assess the safety of these new agents in HIV-infected patients.
As an observatory, the number of participants planned is not predetermined: the aim is to include for 2 years any participant infected with HIV and having a cancer treated by ICPi in one of the centers that have agreed to participate.
50 participants will be recruited for Substudy "OncoVIRIM" during the study period (regardless of tumor type or ICPi type); 8 or 9 time points (blood samples) will be scheduled
The cohort " ANRS CO24 OncoVIHAC " is declared to authorities like category 2 research .
No intervention in the observatory, a collection of data will be carried out in M0, M6, M12, M18 and M24.
For the physiopathological Substudy OncoVIRIM : Blood samples will be collected to constitute cell bank, plasma bank, serum bank, DNA bank in order to meet the objectives of this substudy and possibly for complementary research
- Detailed Description
Primary Objective To evaluate clinical and biological safety of the use of immune checkpoint inhibitors in HIV infected patients with cancer treated by Immune-Checkpoint Inhibitors (ICPi).
Secondary objectives
* To evaluate evolution of HIV immunological and virological data in HIV infected patients with cancer treated by Immune-Checkpoint Inhibitors (ICPi):
* HIV-RNA plasma viral load
* Evolution of CD4+ and CD8+ T cells counts, CD4/CD8 ratio
* To assess the efficacy endpoint : progression-free survival, overall survival rate at 1 year and 2 years.
* Potential Modification of antiretroviral therapy
Secondary objectives of the Physiopathological Substudy "OncoVIRIM" (Limited to a few clinical centers with a suitable technical tray) :
* To evaluate response to ICPi treatment according to RECIST criteria (solid tumor) and CHESON criteria (lymphoma)
* Other immunological and virological explorations on HIV :
* To evaluate low level HIV replication and size of the HIV reservoir
* To evaluate effects of ICPi on HIV-specific immune responses
* To show the effects of ICPi on HIV-related immune alterations such as T cell differentiation, T cell activation/exhaustion and systemic inflammation
* To demonstrate an effect on other viruses-specific T cells and viremia (EBV, CMV, HHV-8, HBV et HCV (if co-infected)
* To better understand the pathophysiology of ICPi-related immune adverse effects, particularly the development of infraclinical auto-immunity : monitoring of autoantibodies and analysis of changes in B cell antibodies repertoires
* To find immune biomarkers predictive for clinical response to ICPi, MHC class I and II in particular and description of any gene of interest in the context of ICPi treatment
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of clinical and biological adverse events occurring with ICPi treatment during the study period 4.5 years
- Secondary Outcome Measures
Name Time Method Immuno-virological evolution between Month0 and Month 24 CD4+ and CD8+ T cells counts /mm3 and %, CD4/CD8 ratio.
Disease status at Month12 and at Month24 Overall response rate
Progression-Free survival at Month6, Month12, Month18, Month24 Progression-Free survival rate
For Physiopathological Substudy "OncoVIRIM" : Objective Response Rate (OPR) At following cures cycles according to the type of treatment : Cycle1 (Week0), Cycle2 (Week2 or Week3), Cycle3 (Week4 or Week6), Cycle9 (Week16) or Cycle9 (Week24), Cycle 15(Week28), Cycle18 (Week52), Cycle27 (Week52), Cycle36 (Week104), Month6, Month12 Objective response rate of patient tumor with ICPi treatment according to RECIST criteria (solid tumor) et CHESON criteria (lymphoma).
The cycles of cures concerned according to the type of treatment :
* Nivolumab with a cure cycle length of 2 weeks : Cycle1(Week0), Cycle2 (Week2), Cycle3 (Week4), Cycle9 (Week16), Cycle15 (Week28), Cycle27 (Week52), Cycle51 (Week100)
* Pembrolizumab with a cure cycle length of 3 weeks : Cycle1 (Week0), Cycle2 (Week3), Cycle3 (Week6), Cycle9 (Week24), Cycle18 (Week52), Cycle36 (Week104)
* Ipilimumab with a cure cycle length of 3 weeks : Cycle1 (Week0), Cycle2(Week3), Cycle3 (Week6), Cycle4 (Week9), Month6, Month12For Physiopathological Substudy "OncoVIRIM" : between Month0 and Month24 Incidence of autoimmune complications and changes in antibodies repertoires of B cell in case of immunological adverse event
For Physiopathological Substudy "OncoVIRIM" : Detailed Immunological and Virological Evolution At following cures cycles according to the type of treatment : Cycle1 (Week0), Cycle2 (Week2 or Week3), Cycle3 (Week4 or Week6), Cycle9 (Week16) or Cycle9 (Week24), Cycle 15(Week28), Cycle18 (Week52), Cycle27 (Week52), Cycle36 (Week104), Month6, Month12 - Systemic inflammation markers and markers of T cell activation, exhaustion, and differentiation
The cycles of cures concerned according to the type of treatment :
* Nivolumab with a cure cycle length of 2 weeks : Cycle1 (Week0), Cycle2 (Week2), Cycle3 (Week4), Cycle9 (Week16), Cycle 15(Week28), Cycle27 (Week52), Cycle51 (Week100), in case of treatment stopped and in case of immunological adverse event.
* Pembrolizumab with a cure cycle length of 3 weeks : Cycle1 (Week0), Cycle2 (Week3), Cycle3 (Week6), Cycle9 (Week24), Cycle18 (Week52), Cycle36 (Week104) in case of treatment stopped and in case of immunological adverse event.
* Ipilimumab with a cure cycle length of 3 weeks : Cycle1 (Week0), Cycle2(Week3), Cycle3 (Week6), Cycle4 (Week9), Month 6, Month 12, in case of treatment stopped and in case of immunological adverse event.For Physiopathological Substudy "OncoVIRIM" : Gene sequencing Week0 Gene sequencing whose interest appears to be major in the responses / adverse effects of ICPi, especially MHC class I and II
Trial Locations
- Locations (56)
Service d'Immunologie - Hôpital Felix Guyon
🇫🇷La Réunion, Saint-Denis, France
Service d'Hématologie Oncologie - Centre Hospitalier du Pays d'Aix
🇫🇷Aix-en-Provence, France
Service de pneumologie - Hôpital Victor Dupouy
🇫🇷Argenteuil, France
Service d'Onco-Hématologie Immunodépression - Hôpital Henri Duffaut
🇫🇷Avignon, France
Service des Maladies Infectieuses et Tropicales - Hôpital Jean Minjoz
🇫🇷Besançon, France
Ambulatoire-Hôpital de Jour - Institut Paoli Calmettes
🇫🇷Marseille, France
Service d'hématologie-Cisih - Hôpital Sainte Marguerite
🇫🇷Marseille, France
Service dermatologie/vénéréologie - Hôpital de la Timone
🇫🇷Marseille, France
Service de Médecine interne - Centre Hospitalier Intercommunal
🇫🇷Créteil, France
Service de pneumologie - Centre Hospitalier Intercommunal
🇫🇷Créteil, France
Service de Médecine interne - Hôpital Antoine Béclère
🇫🇷Clamart, France
Pôle de Médecine 2 - Centre Hospitalier Andrée Rosemon
🇫🇷Cayenne, France
Service de Médecine interne et Maladies infectieuses - Hôpital André Mignot
🇫🇷Le Chesnay, France
Service des Maladies Infectieuses et Tropicales - Hôpital de la Croix Rousse
🇫🇷Lyon, France
Service d'hématologie - Hôpital Gabriel Montpied
🇫🇷Clermont-Ferrand, France
Service des Maladies Infectieuses et Tropicales - Hôpital Gabriel Montpied
🇫🇷Clermont-Ferrand, France
Service des Maladies Infectieuses et Tropicales - Hôpital Pitié-Salpêtrière
🇫🇷Paris, France
Service Hémopathies Lymphoïdes - Hôpital Henri Mondor
🇫🇷Créteil, France
Service Oncologie Hématologie - Hôpital Yves Le Foll
🇫🇷Saint-Brieuc, France
Service des Maladies Infectieuses et Tropicales - Hôpital Purpan
🇫🇷Toulouse, France
Service d'Immunologie Clinique - Hôpital Henri Mondor
🇫🇷Créteil, France
Service Infectiologie - Hôpital de l'Hôtel-Dieu
🇫🇷Paris, France
Service Oncologie Médicale - Centre Hospitalier Intercommunal
🇫🇷Créteil, France
Service de Médecine Interne - Centre Hospitalier de Martigues
🇫🇷Martigues, France
Service des Maladies Infectieuses et Tropicales - Hôpital Gui de Chauliac
🇫🇷Montpellier, France
Service d'hématologie et oncologie - Hôpital André Mignot
🇫🇷Le Chesnay, France
Service de Médecine interne-Immunologie clinique - Hôpital Bicêtre
🇫🇷Le Kremlin-Bicêtre, France
Service d'oncologie multidiscliplinaire - Hôpital Nord
🇫🇷Marseille, France
Service de Dermatologie - Hôpital l'Archet
🇫🇷Nice, France
Service de médecine interne Cancérologie - Hôpital l'Archet
🇫🇷Nice, France
Service d'Oncologie Médicale - Hôpital Pitié-Salpêtrière
🇫🇷Paris, France
Service de dermatologie - Hôpital St Joseph
🇫🇷Marseille, France
Service de Pneumologie - Hôpital St Joseph
🇫🇷Marseille, France
Chirurgie Urologique et Tranplantation Rénale - Hôpital de la Conception
🇫🇷Marseille, France
Service d'Oncologie médicale - Hôpital de la Timone
🇫🇷Marseille, France
Service des Maladies Infectieuses et Tropicales - Hôpital l'Archet
🇫🇷Nice, France
Service des Maladies Infectieuses - Hôpital Saint Antoine
🇫🇷Paris, France
Service des Maladies Infectieuses - Hôpital Saint-Louis
🇫🇷Paris, France
Service Hématologie Clinique - Hôpital Pitié-Salpêtrière
🇫🇷Paris, France
Service d'Immunologie Clinique - Hôpital européen Georges Pompidou
🇫🇷Paris, France
Servide de Dermatologie - Hôpital Saint-Louis
🇫🇷Paris, France
Hôpital Bichat
🇫🇷Paris, France
Service de pneumologie - Hôpital Tenon
🇫🇷Paris, France
Service de pneumologie - Hôpital Yves Le Foll
🇫🇷Saint-Brieuc, France
Service Médecine interne - Maladies Infectieuses - Hôpital Yves Le Foll
🇫🇷Saint-Brieuc, France
Centre Hospitalier Universitaire de Saint Etienne
🇫🇷Saint-Priest-en-Jarez, France
Service de Médecine Interne - Hôpital Foch
🇫🇷Suresnes, France
Service de Médecine Interne - Hôpital d'Instruction des Armées Saint Anne
🇫🇷Toulon, France
Service de Cancérologie Médicale - Hôpital européen Georges Pompidou
🇫🇷Paris, France
Service des Maladies Infectieuses et Tropicales - Hôpital Tenon
🇫🇷Paris, France
Institut de Cancérologie Lucien Neuwirth
🇫🇷Saint-Priest-en-Jarez, France
Service de Pneumologie - Hôpital Foch
🇫🇷Suresnes, France
Département d'Innovation Thérapeutique et d'Essais Précoces - Institut Gustave Roussy
🇫🇷Villejuif, France
Le Trait d'Union - Hôpitaux Universitaires de Strasbourg
🇫🇷Strasbourg, France
Service des Maladies Infectieuses et du Voyageur - Centre Hospitalier de Tourcoing
🇫🇷Tourcoing, France
Service d'immuno-pathologie clinique - Hôpital Saint-Louis
🇫🇷Paris, France